Duff 1982.
Methods | Design: randomised double‐blinded No. eligible: not stated No. randomised: "91 enrolled" No. analysed: 91 Drop‐outs/withdrawals: none reported Years of recruitment: 1979 to 1981 Setting: army medical centre, USA |
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Participants | Inclusion criteria: all women undergoing abdominal hysterectomy for benign disease
Exclusion criteria: antibiotics received in past 4 weeks, penicillin or cephalosporin allergy Age: 39 to 40 years Type of hysterectomy: abdominal |
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Interventions | Treatment: 1 gram cefoxitin (second‐generation cephalosporin) Control: placebo Route: IV Single/multiple doses: multiple Timing of doses: 30 minutes preoperatively and 4 hours later |
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Outcomes | Postoperative infection, early Abdomnal wound infection Urinary tract infection Pelvic infection Need for therapeutic antibiotics Adverse effects (narrative data only) Length of hospital stay |
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Funding | Not stated | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Randomly allocated" ‐ no details given |
Allocation concealment (selection bias) | Low risk | "Only the hospital pharmacist routinely had access to the protocol code before completion of the study" |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | "Both the patient and the attending physician were blinded as to the medication assignment"; no additional details provided with respect to outcome assessment |
Incomplete outcome data (attrition bias) All outcomes | Low risk | It appears that all participants randomised were analysed |
Selective reporting (reporting bias) | Low risk | Outcome data available on all prespecified outcomes |
Other bias | Low risk | Baseline demographic characteristics similar between treatment groups |